HEALTH BUDDY APPLIANCE— 510(k) K050567

Substantially Equivalent

Health Hero Network, Inc.

FDA 510(k) clearance K050567 for HEALTH BUDDY APPLIANCE, Substantially Equivalent on 2005-04-05. Applicant: Health Hero Network, Inc..

Clearance details

Applicant
Health Hero Network, Inc.
Product code
Code DRG
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mountain View, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DRG

product code DRG
Death
5
Total
5

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.